{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221166", "product_res_number": "Z-2857-2026", "event_date_initiated": "2026-06-11", "event_date_posted": "2026-08-03", "recall_status": "Open, Classified", "res_event_number": "99263", "product_code": "OWB", "k_numbers": [ "K252068" ], "product_description": "Brand Name: OXOS Medical, Inc\nProduct Name: MC2 Portable X-Ray System\nModel/Catalog Number: MC2, MC2.1\nSoftware Version: 5.7.0\nProduct Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with point of care visualization through diagnostic x-rays of extremities and shoulders. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and can be charged with either a wired or wireless charger. The system is intended to interface wirelessly to an external tablet or display when used with the OXOS Device App. The MC2 utilizes an infrared Tracking System and Viewfinder that allows the operator to position the emitter within a safe source-to-image distance (SID) and allows the operator to visualize the anatomy and x-ray field projection prior to initiating an x-ray acquisition. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.\nComponent: The MC2 Portable X-Ray System is not a component.", "code_info": "Lot Code: MC2; UDI 00860008892782; Serial Numbers 1523, 1527, 1488, 1528, 1529, 1544\n\nMC2.1; UDI 00850079606043; Serial Numbers: 1461, 1462, 1547\n\nFull UDI for affected devices:\n(01)00860008892782(11)260107(21)1523\n(01)00860008892782(11)260129(21)1527\n(01)00860008892782(11)260109(21)1488\n(01)00860008892782(11)260123(21)1528\n(01)00860008892782(11)260130(21)1529\n(01)00860008892782(11)260227(21)1544\n(01)00850079606043(11)260407(21)1461\n(01)00850079606043(11)260407(21)1462\n(01)00850079606043(11)260408(21)1547", "firm_fei_number": "3018077344", "recalling_firm": "Oxos Medical Inc", "address_1": "1100 Peachtree St Ne Ste 700 1100 Peachtree St Ne", "address_2": "Ste 700", "city": "Atlanta", "state": "GA", "postal_code": "30309-4516", "additional_info_contact": "Fred Ginnebaugh\n001-855-7339729", "reason_for_recall": "Due to a defective circuit board that overheats", "root_cause_description": "Process change control", "action": "On 06/12/2026, an \"URGENT: Medical Device Recall - Limited to Specific MC2 Units\" letter was emailed to customers informing them that, due to faulty circuit boards limited units may experience localized overheating.\n\nAs a result the firm released a software update (version 5.7.0) which will place a unit in a safe state if boards fail.\n\nCustomers are instructed to:\n1. Update units to software version 5.7.0 via over-air updates. Note, it is important to apply the software update to continue using the MC2 units\n2. In addition to the software update, OXOS will replace the defective components with the cassette as part of a scheduled procedure. The MC2 must be returned to OXOS headquarters for replacement of affected components. Servicing will coordinate with customers to minimized any inconvenience.\n3. Customer need to acknowledge receipt of the recall communication and complete the software update by calling OXOS Support Team at 866-749-4229 to schedule a time to perform the updated by emailing support#oxos.com, or accepting the update on their devices.\n\nFor questions or assistance - contact Support Team at 866-749-4229 or email support@oxos.com.", "product_quantity": "77", "distribution_pattern": "US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.", "openfda": { "k_number": [ "K253584", "K170752", "K170144", "K192182", "K170909", "K142126", "K970734", "K052412", "K180473", "K232420", "K161839", "K051064", "K210309", "K250010", "K251523", "K113403", "K122644", "K062623", "K093688", "K121444", "K201743", "K181943", "K024200", "K183040", "K070123", "K232298", "K233200", "K083545", "K912448", "K062647", "K172646", "K162148", "K021049", "K061953", "K142736", "K251199", "K022322", "K253670", "K190064", "K251602", "K961374", "K993037", "K100102", "K233748", "K153147", 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"1000517638", "3009196578", "3012761544", "2027467", "3012939903", "3014391847", "3012624817", "3003202425", "3008496839", "3022378058", "3000126629", "3002807041", "3018094310", "3013184485", "3009973505", "1720753", "3033525987", "3006128100", "3030412764", "3009715136", "3031503890", "3004754211", "3006972752", "3009001657", "3042175844", "3008044777", "3016619943", "3017375271", "3021059265", "3000205591", "3010685285", "2939520", "3011347852", "3016438694" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }